The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children:A Randomised Controlled Trial

University of Malaya

Status

Completed

Conditions

Dental Anxiety

Treatments

Behavioral: Virtual Reality Exposure

Study type

Interventional

Funder types

Other

Identifiers

NCT05854329

DF CD2313/0024 (P)

Details and patient eligibility

About

The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question[s] it aims to answer are:

Is there a significant difference in baseline dental anxiety scores, as measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
What is the mean change score in dental anxiety measured using the Malay-MCDASf and PR for IVRE, NIVRE, and control groups after the operative procedure?
Is there a significant difference in mean change score of dental anxiety measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
Is there a significant correlation between the Malay-MCDASf scores (subjective) and PR scores (objective) at preoperative, postoperative, and using the score changes for all groups?

Full description

Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.

Enrollment

66 patients

Sex

All

Ages

9 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children aged 9-12 years old.
Children who can understand and complete the Malay-MCDASf questionnaire with a score of 19 and above.
Children who requires fissure sealants on sound permanent tooth.

Exclusion criteria

Children requiring emergency dental treatment for pain, trauma or facial cellulitis.
Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months.
Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems
Parents who refuse to allow their children to participate in the trial.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 3 patient groups

Immersive Virtual Reality Exposure

Experimental group

Description:

Immersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist.

Treatment:

Behavioral: Virtual Reality Exposure

Non-Immersive Virtual Reality Exposure

Active Comparator group

Description:

Participants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes.

Treatment:

Behavioral: Virtual Reality Exposure

Control Group

No Intervention group

Description:

Participants will be waiting for 15 minutes as usual prior to their treatment.